MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBWGQ506A2

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the set in question was not returned for investigation.We therefore conducted investigations based on the provided information.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukoreduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the reported lot number and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.In addition, we investigated dope material used for the reported lot number and found that the viscosity of pu solution of dope material conformed to the standards.Release testing, which includes measurements of solution concentration and volume and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all release testing items.The product conformed to the standards.Regarding the retained sample of the reported lot number, three sets were visually examined.There were no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Root cause : we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.

Manufacturer Narrative

This report is being filed to provide corrected information in d.9, h.3, h.6 and h.10.Corrected investigation: we received the red blood cell bag and the leukoreduction filter.The filter was rinsed with normal saline.The normal saline flowed very fast at a flow rate of 117 ml/min.We disassembled the rinsed filter to observe the appearance of filter membranes.We noticed creases in the filter membranes of the filter.The creases in the filter were not different from those in conforming products.Aggregation was not observed in any filter membranes.An airtightness test was performed on the filter in accordance with the following procedures and we confirmed that air leaks were not observed in any locations of the filter.After passing normal saline through the filter, we dyed the filter membranes with toluidine blue for observation and noticed that some areas of the fifth and sixth filter membranes had been dyed dark.That is, white blood cells were accumulated in these dyed areas.Concerning the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray is heat-sealed.For the leukoreduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the reported lot number and confirmed that no anomalies occurred in any process, and the product in question was manufactured as usual.In addition, we investigated dope material used for the reported lot number and found that the viscosity of pu solution of dope material conformed to the standards.Shipping testing, including measurements of solution concentration and volume, and a visual inspection, is performed on the product concerned as sampling testing.We therefore reviewed each testing and inspection record of the reported lot number and confirmed that there were no anomalies in all shipping testing items.The product conformed to the standards.Regarding the retained sample of the reported lot number, three sets were visually examined.There were no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Corrected root cause: we control to maintain cationization levels above a certain level during the production of filter membranes in order to prevent from leukocyte leakage.Where a cationization level is high, filtration rate is likely to be low.For the prevention of leukocyte leakage, the instructions for use of the product state: "[caution] do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood", and "clamp the blood filled tubing before blood enters the filter".The above-mentioned investigation results revealed that there were no abnormalities in the manufacturing record and the testing and inspection record of the reported lot number.The returned filter also revealed no abnormalities in themselves.We noticed that the fifth and sixth filter membranes were locally dyed dark with toluidine blue.Therefore, occlusion may have occurred and blood may have been filtered by the filter area which was smaller than usual and the linear speed (flow rate per unit area) increased, and then leukocyte leakage occurred.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• MDR Report Key: 10420733
• MDR Text Key: 223443982
• Report Number: 9681839-2020-00090
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 200325AG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 08/18/2020; 11/11/2020
• Supplement Dates FDA Received: 09/11/2020; 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other